Hydrogen Group
Location: Remote
Schedule: Standard Office Hours
Duration: 6-Month Contract (paternity leave)
Pay Rate Range: $100.00/ph - $120.00/ph
The Advertising Promotion Associate Director provides regulatory support and guidance for product and disease state communications, ensuring compliance with applicable regulations. This role involves reviewing and approving promotional materials, collaborating with cross-functional teams, and interpreting regulatory guidelines.
- Provide regulatory expertise on advertising and promotional communications.
- Review and approve promotional materials for compliance.
- Serve as a regulatory reviewer on cross-functional committees.
- Lead discussions between Regulatory, Legal, Medical, and Commercial teams.
- Interpret and apply relevant regulations, guidance, and industry standards.
- Assess promotional claims based on clinical study design and statistical analyses.
- Ensure compliance with labeling changes in promotional materials.
- Develop and update internal procedures and guidelines for review processes.
- Monitor regulatory developments and assess their impact.
- Conduct training sessions for stakeholders.
- Strong knowledge of US regulations and industry standards for pharmaceutical advertising and promotion.
- Understanding of clinical study design and statistical analyses.
- Excellent interpersonal and communication skills.
- Ability to analyze complex regulatory issues and provide strategic solutions.
- Experience interacting with regulatory bodies such as OPDP/APLB.
- Bachelor's degree in a relevant scientific discipline.
- Minimum of 8 years of experience in pharmaceutical advertising and promotion regulatory roles.
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